PE Global are currently recruiting for a Qualified Person for a 12 month contract role with a leading multinational Pharma client based in Runcorn.
To perform final QP Batch Certification to ensure that all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, in accordance with EU, USA, or other requirements e.g. Russia, Brazil, Canada.
Job Responsibilities
• To ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
• To verify all batch related documentation is compliant with the requirements of the regulatory authorities.
• To review and certify batches in line with business shipment schedules.
• To ensure Product Licences (Marketing Authorisations), ANDAs, Manufacturer's Licence, Technical Agreements, CE Certification requirements have been met to ensure compliance.
• To ensure planned changes or deviations are supported by appropriate sampling, inspection, testing and check to ensure compliance with the requirements of the regulatory authorities.
• To ensure planned changes or deviations in manufacturing or quality control have been notified in accordance with well-defined reporting system.
• To ensure that manufacturing and testing processes have been validated and all the necessary checks and tests have been performed.
• To ensure appropriate audits, self-inspections and spot checks are carried out by experienced staff.
Requirements
• Qualified to Degree level or equivalent in science.
• Membership of appropriate professional body.
• Registration as a Qualified Person, with acceptability to the Licensing Authority
• Significant experience in a senior Quality role with experience as a Quality Leader in a modern manufacturing environment within the pharmaceutical industry.
• Good communicator and team worker with the ability to set and deliver high performance standards relating to quality, safety, cost and customer service.
Interested candidates should submit an up to date CV.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert